Johnson & Johnson MedTech · 17 hours ago
Principal Production Engineer
Danvers, MA
Full-time
Onsite
Senior Level, Lead/Staff
$100K/yr - $172K/yr
10+ years expJohnson & Johnson MedTech is committed to healthcare innovation, aiming to improve patient outcomes through advanced medical technologies. The Principal Production Engineer will provide strategic and hands-on leadership across manufacturing operations for complex electro-mechanical medical devices, focusing on scale-up, process validation, and continuous improvement initiatives.
Hospital & Health Care
Responsibilities
Define and drive the manufacturing strategy and technology roadmap for scale-up, capital projects, and process automation
Lead critical programs from concept through commercialization, ensuring alignment with regulatory, quality, and business goals
Own scale-up from pilot/early production to full-scale manufacturing; manage design transfer activities with cross-functional teams
Develop robust manufacturing readiness plans, including process mapping, equipment qualification, and line layout optimization
Lead IQ/OQ/PQ strategies for equipment, processes, packaging, and software where applicable
Develop validation protocols, execute plans, analyze results, and secure sign-off; ensure traceability to user needs and regulatory requirements
Champion structured problem solving for yield issues, quality escapes, and process deviations
Drive CAPA execution, verify effectiveness, and close with data-backed evidence and sustainability
Maintain alignment with regulatory expectations (e.g., FDA QSR/21 CFR Part 820, ISO 13485) and support regulatory submissions as needed
Lead Lean/Six Sigma initiatives to improve throughput, reduce cycle times, increase yield, and lower cost per unit
Apply DOE, SPC, MSA, Cp/Cpk analyses and other advanced analytics to optimize processes and sustain gains
Define and track KPIs (yield, scrap rate, OEE, CAPA closure, cycle time) and provide actionable insights to leadership
Develop dashboards and storytelling visuals to communicate program status and risks
Partner with Quality, Regulatory, R&D, Supply Chain, and Operations to align on milestones, risks, and resource needs
Mentor and coach engineers and technicians; foster a culture of continuous improvement and knowledge sharing
Qualification
Required
Bachelor's degree in Mechanical, Industrial, Biomedical, or related Engineering; Master's degree or equivalent experience preferred
10+ years in manufacturing engineering or operations within medical devices or complex product environments
Deep understanding of FDA QSR/21 CFR Part 820 and ISO 13485
Experience with design controls, design transfer, validation activities, and quality systems in a regulated setting
Proficient in DOE, SPC, MSA, Cp/Cpk, PFMEA, Control Plans, and CAPA management
Knowledge of manufacturing processes (e.g., plastics, polymers, adhesives, molding, assembly, packaging, sterilization) as relevant to the product line
Experience with change control, CAPA, PFMEA, control plans, and documentation management
Excellent problem-solving, communication, and project-management skills
Demonstrated ability to lead large-scale programs and mentor diverse teams
Preferred
Benchmarking
Coaching
Critical Thinking
Facility Management
Leading Change
Lean Manufacturing Principles
Lean Supply Chain Management
Manufacturing Engineering
Manufacturing Flow Management
Organizing
Performance Measurement
Predictive Maintenance
Product Design
Program Management
Project Schedule
Safety-Oriented
Science, Technology, Engineering, and Math (STEM) Application
Strategic Thinking
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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